Label: ZINC OXIDE 20%- zinc oxide ointment

  • NDC Code(s): 69396-086-02
  • Packager: Trifecta Pharmaceuticals USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • Protects skin
    • Protects and releives chafed skin due to diaper rash - helps seal out wetness
    • Dries the oozing and weeping of poison ivy, oak and sumac
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    For External Use Only

    • When using this product avoid contact with eyes
  • Stop Use and ask Doctor if

    Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

  • Directions

    • Apply ointment liberally as often as necessary
    • For the treatment of diaper rash, change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged
  • Other Information

    • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Inactive Ingredients

    Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum

  • Distributed By:

    Trifecta Pharmaceuticals USA, LLC.®

    101 NE Third Avenue, Ste. 1500

    Ft. Lauderdale, FL. 33301, USA.

    www.trifecta-pharma.com

  • Questions

    Call 1-888-296-9067

  • PRINCIPAL DISPLAY PANEL

    Globe Zinc Oxide Ointment 2oz India Rev09 042323 CDER

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-086-021 in 1 BOX05/30/2023
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/30/2023
    Labeler - Trifecta Pharmaceuticals USA (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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